The American biopharmaceutical multinational, Amgen Inc. (AMGN, Financial), will end its collaborative initiatives with AstraZeneca plc (AZN, Financial), the British pharmaceutical and biologics company, in the development of a drug Brodalumab for psoriasis and psoriatic arthritis. This decision was made when the Phase III clinical drug trials revealed suicidal tendencies among the tested patients. Foreseeing curtailed scope of usage, Amgen representatives said in an official statement on May 22 that it has decided to end the partnership "basedon events of suicidal ideation and behaviour in the Brodalumab program, which Amgen believes likely would necessitate restrictive labelling."
Meanwhile, AstraZeneca is still weighing its options in the drug development program by reviewing all recorded data. In a London Stock Exchange statement on May 26, AstraZeneca said itwill confirm its decision on the future development of Brodalumab as soon as possible based on further review of the data.
The Brodalumab development program
Amgen, the world’s largest biotechnology firm, partnered with AstraZeneca, the world's seventh-largest pharmaceutical company in terms of prescription drug sales, in April 2012 in a collaboration agreement to jointly research and commercially develop five monoclonal antibodies for treatment of inflammatory diseases. Of all the drugs being developed in the joint venture aimed at psoriasis, asthma, Crohn’s disease and ulcerative colitis, Brodalumab aimed at curing moderate to severe plaque psoriasis, axial spondyloarthritis and psoriatic arthritis and had progressed furthest into clinical trials. With Amgen, holding a net income of $5.158 billion in 2014 providing access to the drug prototype from its profile, AstraZeneca invested $50 million initially and agreed to shoulder 65% of development cost from 2012 to 2014 in return of even profit sharing post successful launch of the drug.
The drug started its phase III clinical trial phase on November 2013 with the companies reporting encouraging results for the compound a year later. The collaboration would have worked on the processing of the new drug application at the U.S. Food and Drug Administration and regulatory filings, but the safety worries and suicidal worries have prompted the pharmaceutical major to withdraw from the co-development deal serving a big blow to its partner’s long term plans and financial prospects. Analysts had predicted almost $811 million sales for the new revolutionary drug in 2023, while AstraZeneca was banking on the estimated peak sales of $500 million to $1.5 billion of the commercialised new drug to drive its revenue goal of delivering $45 billion in 2023 from $26.095 billion in 2014. The cost effective deal was viewed as the perfect way to broaden AstraZeneca’s capabilities in the face of recent patent conflicts and setbacks due to failure of its ovarian cancer as well depression prototypes in drug trials.
Way ahead
Amgen has moved ahead from the aborted deal with its cholesterol inhibiting drug Repatha winning European Medicines Agency's approval, providing a golden opportunity to be the first to market the much-awaited cholesterol fighter and capitalise on its potential success. The way ahead for AstraZeneca is a little tougher as with the termination of the joint deal, the responsibility for developing and commercializing the new drug after applying for regulatory approvals in all territories falls solely on its shoulders. With the psoriasis drug market already laden with products like Enbrel, Cosentyx, Stelara and Otezla, AstraZeneca has to handle its Brodalumab strategically.
